Evaluating the Efficacy and Safety of TJO-087 in Moderate to Severe Dry Eye Disease Patients

A Phase Ⅲ, Multicenter, Randomized, Double-blind, Active-controlled, Parallel Study of TJO-087 for Evaluating 32 Weeks Safety and Efficacy in Moderate to Severe Dry Eye Disease Patients

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05245604

Enrollment

182

Registered

2022-02-18

Start date

2020-06-19

Completion date

2023-04-30

Last updated

2022-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndrome

Brief summary

The purpose of this clinical study is to prove that the test drug (TJO-087) is not clinically inferior to the control drug after 32 weeks of administration to patients with suppressed tear production due to moderate or severe dry eye syndrome.

Interventions

DRUGTJO-087

Cyclosporine ophthalmic nano-emulsion 0.08%, 1 drop once daily

DRUGCyclosporine ophthalmic solution 0.05%

Cyclosporine ophthalmic solution 0.05%, 1 drop twice/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female, age 20 or over * Patients with moderate to severe dry eye * Screening both eyes, the corrected visual acuity is 0.2 or more * Written informed consent to participate in the trial

Exclusion criteria

* Screening visits within 2 weeks who treated with topical NSAIDs/hyaluronate sodium ophthalmic solutions * Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease) * Intraocular pressure(IOP)\> 25 mmHg * Patient using or to use punctual plug within 1 months. * Patients with contact lens.

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Non-anesthetic Schirmer Test at Week 32	Baseline and Week 32	The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.

Secondary

Measure	Time frame	Description
Change From Baseline in Non-anesthetic Schirmer Test at Week 8, 16, 24	Baseline, Week 8, 16 and 24	The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.
Change From Baseline in Corneal Fluorescein Staining Score at Week 8, 16, 24 and 32	Baseline, Week 8, 16, 24 and 32	Change from Baseline in corneal staining of the worse eye using blue fluorescein staining procedure.

Countries

South Korea

Contacts

Primary ContactSukyoung Kwon

skkwon@taejoon.co.kr82-2-799-0184

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026